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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000014614
Receipt No. R000015412
Scientific Title Objective evaluation of pain
Date of disclosure of the study information 2014/08/01
Last modified on 2018/02/04

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Basic information
Public title Objective evaluation of pain
Acronym Objective evaluation of pain
Scientific Title Objective evaluation of pain
Scientific Title:Acronym Objective evaluation of pain
Region
Japan

Condition
Condition healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We are going to seek the objective way for evaluating pain
Basic objectives2 Others
Basic objectives -Others We are going to measure various vital signs including ECG and skin conductance during painful and non-painful stimulus for seeking the objective way for evaluating pain.
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes 1. We are going to investigate the relationship between numerical rating scale and vital signs including skin conductance, heart rate variability, and arterial oxygen saturation during heat stimulation.
2. We are going to compare the changes in skin conductance after 5 different stimuli.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment Other
Interventions/Control_1 The device for heat and mechanical stimulation, skin conductance monitor,audiometer
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
60 years-old >=
Gender Male and Female
Key inclusion criteria Healthy adults between 20 and 60 years old with informed consent
Key exclusion criteria Subject with chronic pain
Subject who can not understand the protocol
Subject who can not tolerate heat stimulus
Subject who has a medication acting on autonomic nerve system
Subject who is not suitable for giving heat stimulus due to severe disease
Pregnant woman
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satomi Sugimine
Organization Gunma University Hospital
Division name Department of Anesthesiology
Zip code
Address 3-39-15 Showa-machi, Maebashi, Gunma 371-8511, Japan
TEL 027-220-8454
Email s-satomi@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satomi Sugimine
Organization Gunma University Hospital
Division name Department of Anesthesiology
Zip code
Address 3-39-15 Showa-machi, Maebashi, Gunma 371-8511, Japan
TEL 027-220-8454
Homepage URL
Email s-satomi@umin.ac.jp

Sponsor
Institute Department of Anesthesiology, Gunma University Graduate School of Medicine
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 群馬大学医学部附属病院(群馬県)

Other administrative information
Date of disclosure of the study information
2014 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2013 Year 04 Month 24 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 07 Month 22 Day
Last modified on
2018 Year 02 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015412

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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